Surgical navigation devices and methods

ABSTRACT

A trajectory frame for use with surgical navigation systems includes a base having a patient access aperture formed therein. A yoke is mounted to the base and is rotatable about a roll axis. A platform is mounted to the yoke and is rotatable about a pitch axis. An elongated guide is secured to the platform and includes opposite proximal and distal end portions and a bore that extends from the proximal end portion to the distal end portion. The guide is configured to removably receive various devices therein for quick release therefrom, including an optical tracking probe (which may be a universal tracker) detectable by a camera-based tracking system or an EM probe detectable by an EM navigation system, a microelectrode probe driver adapter, a drill guide and drill bit, skull fixation device and driver, and a catheter guide.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/781,049, which claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 61/673,583 filed Jul. 19, 2012.This application also claims the benefit of and priority to U.S.Provisional Application Ser. No. 61/891,661, filed Oct. 16, 2013. Thecontents of the above documents are incorporated herein by reference asif set forth in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical systems and methodsand, more particularly, to in vivo medical systems and methods.

BACKGROUND

During image guided surgeries, it can be desired to drill through bonesuch as a skull to define a surgical path for passing medicalinterventional devices.

SUMMARY

Embodiments of the present invention provide methods, devices andsystems for localized placement and/or delivery of diagnostic ortherapeutic devices or substances.

According to embodiments of the present invention, an image guidedinterventional system includes a frame with a support column and aremovable, cooperating tubular adapter. The base of the frame isconfigured to be secured to the body of a patient, and is configured totranslate and rotate such that the support column can be oriented to adesired intrabody trajectory.

Embodiments of the present invention may be particularly suitable forplacing neuro-modulation leads, such as Deep Brain Stimulation (“DBS”)leads, implantable parasympathetic or sympathetic nerve chain leadsand/or CNS stimulation leads, as well as other devices within the brain.

Embodiments of the present invention may be suitable for a number ofinterventional procedures in many locations inside the body including,but not limited to, brain, cardiac, spinal, urethral, and the like.

Embodiments of the present invention may be suitable for a number ofimage guided drug delivery procedures to intra-brain or other intra-bodytargeted locations.

Embodiments of the present invention may be suitable for a number ofimage-guided tumor removal procedures.

A plurality of user-activatable actuators can be operably connected tothe frame and configured to translate and rotate the frame relative tothe body of a patient so as to position the support column to define adesired intrabody trajectory. In some embodiments, the actuators aredials or thumbscrew-type devices that allow manual manipulation thereof.In other embodiments, the actuators are manipulated remotely usingremote controls and cables.

The support column can include an axially-extending guide boretherethrough that is configured to guide placement of an interventionaldevice in vivo. Various instrumentation and equipment (e.g., stimulationleads, ablation probes or catheters, injection or fluid deliverydevices, biopsy needles, extraction tools, etc.) can be inserted throughthe support column to execute diagnostic and/or surgical procedures.

According to some embodiments of the present invention, the frameincludes a base, a yoke movably mounted to the base and that isrotatable about a roll axis, and a platform movably mounted to the yokeand that is rotatable about a pitch axis. The platform includes an X-Ysupport table that is configured to move in an X-direction andY-direction relative to the platform. The base has a patient accessaperture formed therein, and is configured to be secured to the body ofa patient such that the aperture overlies an opening in the body. A rollactuator is operably connected to the yoke and is configured to rotatethe yoke about the roll axis. A pitch actuator is operably connected tothe platform and is configured to rotate the platform about the pitchaxis. An X-direction actuator is operably connected to the platform andis configured to move the X-Y support table in the X-direction. AY-direction actuator is operably connected to the platform and isconfigured to move the X-Y support table in the Y-direction.

The base may include a plurality of locations for attachment to a bodyof a patient via fasteners. In some embodiments, one or more attachmentlocations may include multiple adjacent apertures configured to receivea fastener therethrough. For embodiments where the frame is configuredto be attached to the skull of a patient, the base can be configured tobe secured to the skull of a patient such that the patient accessaperture overlies a burr hole formed in the patient skull.

According to some embodiments of the present invention, the yokeincludes a pair of spaced apart arcuate arms. The platform engages andmoves along the yoke arcuate arms when rotated about the pitch axis. Thebase includes at least one arcuate arm. The yoke engages and moves alongthe base arcuate arm when rotated about the roll axis.

According to some embodiments of the present invention, at least one ofthe yoke arcuate arms includes a thread pattern formed in a surfacethereof. The pitch actuator includes a rotatable worm with teethconfigured to engage the thread pattern. Rotation of the worm causes theplatform to rotate about the pitch axis. Similarly, at least one of thebase arcuate arms includes a thread pattern formed in a surface thereof.The roll actuator includes a rotatable worm with teeth configured toengage the thread pattern, and wherein rotation of the worm causes theyoke to rotate about the roll axis.

In some embodiments, the actuators are color-coded such that eachdifferent actuator has a respective different color. This allows a userto quickly determine which actuator is the correct one for a particulardesired movement of the frame.

An elongated tubular guide extends through the platform and yoke along aZ-direction and includes opposite proximal and distal end portions. Theguide distal end portion is positioned proximate the patient accessaperture. The guide includes a bore therethrough that extends from theproximal end portion to the distal end portion, and the guide isconfigured to removably receive different devices within the bore. Thedevices may have different sizes and configuration. Exemplary devicesinclude a tracking device with an array of optical fiducials, amicroelectrode drive, a catheter guide, etc.

In some embodiments of the present invention, the guide proximal endportion includes threads formed therein that are configured tothreadingly engage a portion of a device inserted within the guide forquick release therefrom. In other embodiments of the present invention,the guide proximal end portion is configured to removably retain aportion of a device inserted within the guide for quick releasetherefrom, without the use of threads. For example, the guide proximalend portion may include a detent, or other type of structure (shapeand/or component), formed therein, and a device includes a portionhaving a protrusion configured to engage the detent so as to removablysecure the device to the guide via a snap fit. Alternatively, the guideproximal end portion may include a protrusion and the device may includea portion having a detent formed therein that is configured to engagethe protrusion so as to removably secure the device to the guide via asnap fit. The term “quick release,” as used herein, means that atechnician or other user can quickly (e.g., typically in under about 1minute or under about 30 seconds) remove a device from the guide withlittle effort and without requiring tools.

According to some embodiments of the present invention, a medicalassembly includes a trajectory frame and a plurality of devices that arereleasably and serially inserted within the frame so as to be positionedadjacent to a body of a patient. Exemplary devices include a trackingdevice with an array of optical fiducials, a microelectrode drive, acatheter guide, a targeting cannula, a drill guide and drill bit, askull fixation device and driver, and the like.

The frame includes a base configured to be secured to the body of apatient and having a patient access aperture formed therein, a yokemovably mounted to the base and rotatable about a roll axis, and aplatform movably mounted to the yoke and rotatable about a pitch axis.The platform may include an X-Y support table movably mounted theretothat is configured to move in an X-direction and Y-direction relative tothe platform. An elongated guide is secured to the X-Y support table andincludes opposite proximal and distal end portions, and a boretherethrough that extends from the proximal end portion to the distalend portion. The guide distal end portion is positioned proximate thepatient access aperture. A device is inserted within the bore, andincludes opposite proximal and distal end portions. The device distalend portion is positioned proximate the patient access aperture, and thedevice proximal end portion is removably secured to the guide proximalend portion.

In some embodiments, the guide proximal end portion includes threadsformed therein, and the device comprises a portion configured tothreadingly engage the guide proximal end portion. In other embodiments,the device may include a portion configured to be removably secured tothe guide proximal end portion via a snap fit. In yet furtherembodiments, the guide proximal end portion includes at least one slotand the device is removably secured within the guide bore via at leastone member extending outwardly from the device that cooperates with theat least one slot.

In some embodiments, the guide is removably secured to the X-Y supporttable such that the guide can be removed and replaced with another guideof a different size/configuration.

According to some embodiments of the present invention, aninterventional method includes affixing a frame with a cooperating guideto the skull of a patient, inserting an adapter holding a tracking probewith an array of optical fiducials within the guide, tracking thefiducials using a camera system, and removing the adapter from theguide.

The method may be carried out in a conventional operating room usingoff-the-shelf image guided systems without requiring modification tooperational software.

The method may be carried out in an operating room using a camera basedtracking system.

The method may be carried out using images acquired from a CT scannerduring the procedure and/or using pre-acquired MRI images (typically,for neuro-using both pre-acquired MRI brain images and CT images at oneor times during the procedure).

The method may optionally be carried out in an MRI suite.

The method may further include removably securing a drill guide withinthe guide, inserting a drill bit within the lumen of the drill guide,and drilling a hole within the skull of the patient at the incision viathe drill bit. The method may further include removing the drill guideand drill bit from the targeting cannula, removably securing a skull(and/or scalp) fixation device to a distal end of the targeting cannulaguide, removably inserting a skull (and/or scalp) fixation device driverwithin the targeting cannula guide, wherein the fixation device driveris configured to cooperate with the skull and/or scalp fixation device,and rotating the skull fixation device driver to cause the fixationdevice to be inserted within the hole in the skull of the patient. Thefixation device driver is removed from the guide, a catheter guide isremovably secured within the guide, and a catheter is advanced throughthe catheter guide.

It is noted that aspects of the invention described with respect to oneembodiment may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a block diagram of an MRI-guided interventional system,according to some embodiments of the present invention.

FIG. 1B illustrates a user interface that displays, and that allows auser to adjust, the trajectory of a targeting cannula, according to someembodiments of the present invention.

FIG. 2A is a top perspective view of a burr hole formed in the skull ofa patient, and a burr hole ring overlying the burr hole and secured tothe skull.

FIG. 2B is a top perspective view of a removable centering devicepositioned on the burr hole ring of FIG. 1A.

FIG. 3A is a top, side perspective view of a trajectory frame utilizedin a MRI-guided interventional system, according to some embodiments ofthe present invention.

FIGS. 3B-3E are side view, schematic, sequential illustrations of atrajectory frame being secured to the skull of a patient.

FIGS. 4-5 are partial top perspective views of the trajectory frame ofFIG. 3A illustrating the base of the trajectory frame being positionedon the skull of a patient with the centering device of FIG. 2B extendingthrough the patient access aperture.

FIG. 6 illustrates the base of the trajectory frame of FIG. 3A securedto the skull of a patient.

FIG. 7 is an enlarged partial perspective view of the base of thetrajectory frame of FIG. 3A illustrating an attachment location with apair of adjacent apertures for receiving fasteners therethrough,according to some embodiments of the present invention.

FIG. 8A is a perspective view of the trajectory frame of FIG. 3A securedto the body (e.g., skull) of a patient, and with the targeting cannulain an extended position.

FIG. 8B is a cut-away perspective view of the trajectory frame of FIG.3A, illustrating a guide with a targeting cannula therein according tosome embodiments of the present invention.

FIG. 9 is a perspective view of the base of the trajectory frame of FIG.3A illustrating fiducial markers associated therewith and illustratingan arcuate arm with a thread pattern formed in a surface thereof that isconfigured to be engaged by a roll axis actuator, according to someembodiments of the present invention.

FIG. 10 is a partial perspective view of the trajectory frame of FIG. 3Aillustrating a yoke arcuate arm with a thread pattern formed in asurface thereof that is configured to be engaged by a pitch axisactuator, according to some embodiments of the present invention.

FIG. 11 illustrates the trajectory frame of FIG. 3A secured to the skullof a patient and illustrates a desired trajectory for an interventionaldevice, and also illustrates the actual trajectory of the interventionaldevice as oriented by the frame.

FIG. 12 illustrates the frame of FIG. 11 after reorientation viamanipulation of one or more trajectory frame actuators such that theactual trajectory is adjusted to be in alignment with the desiredtrajectory.

FIG. 13 is a partial exploded perspective view of a trajectory frameutilized in an MRI-guided interventional system, according to someembodiments of the present invention, wherein a guide includes athreaded proximal end portion for removably retaining a cap thereon thatis configured to cover a targeting cannula and other devices insertedwithin the guide.

FIG. 14 illustrates the targeting cannula of FIG. 13 inserted within theguide and the cap removably secured to the guide proximal end portion.

FIG. 15A is a partial exploded perspective view of a trajectory frameutilized in an MRI-guided interventional system, according to someembodiments of the present invention, wherein a guide includes athreaded proximal end portion for removably retaining a drill guideinserted within the guide.

FIG. 15B illustrates the drill guide of FIG. 15A inserted within theguide and the threaded end of the drill guide threadingly secured to thethreaded proximal end portion of the guide.

FIG. 16A is a partial exploded perspective view of a trajectory frameutilized in an MRI-guided interventional system, according to someembodiments of the present invention, and configured to removablyreceive a skull fixation device driver within the guide and a skullfixation device at the guide distal end.

FIG. 16B illustrates the skull fixation device driver inserted withinthe guide via the proximal end portion thereof and the skull fixationdevice removably secured to the guide distal end.

FIG. 17 is a side view of the trajectory frame of FIG. 16B.

FIG. 18A is a partial exploded perspective view of a trajectory frameutilized in an MRI-guided interventional system, according to someembodiments of the present invention, and configured to removablyreceive a catheter guide within the guide.

FIG. 18B is a perspective view of the trajectory frame of FIG. 18A andillustrating the catheter guide inserted within the guide and with a capof the catheter guide secured to the proximal end portion of the guide.

FIG. 19 is a perspective view of the trajectory frame of FIG. 18B andillustrating a catheter or other device advanced through the catheterguide of FIG. 18B.

FIG. 20A is a partial exploded perspective view of a trajectory frame,according to some embodiments of the present invention, wherein thetrajectory frame includes a guide for removably receiving and securing atargeting cannula or other device therewithin.

FIG. 20B illustrates the targeting cannula of FIG. 20A inserted withinand secured to the guide.

FIG. 21 is a side perspective view of a trajectory frame with an opticaltracking probe according to embodiments of the present invention.

FIG. 22A is a side perspective view of a trajectory frame with both anoptical tracking probe and an optical reference frame attached to thetrajectory frame according to embodiments of the present invention.

FIG. 22B is a side perspective view of a trajectory frame with anoptical tracking probe with a through channel with image fiducials(e.g., fluid-filled segments detectable in MRI and/or CT images) and anoptional optical reference frame attached to the trajectory frameaccording to embodiments of the present invention.

FIG. 23A is a side perspective view of a tracking probe mount holdingthe tracking probe for releasable attachment to the support column ofthe trajectory frame shown in FIGS. 21 and 22A according to embodimentsof the present invention.

FIGS. 23B and 23C are side perspective views of exemplary tracking probemounts, shown without the tracking probe, according to embodiments ofthe present invention.

FIG. 23D is a side perspective view of a tracking probe mount holdingthe tracking probe for releasable attachment to the support column ofthe trajectory frame shown in FIG. 22B according to embodiments of thepresent invention.

FIGS. 23E and 23F are side perspective views of exemplary tracking probemounts, shown without the tracking probe, according to embodiments ofthe present invention.

FIG. 23G is a section view of an exemplary tracking probe mount shown inFIGS. 23E/23F according to embodiments of the present invention.

FIG. 24 is a side perspective view of the trajectory frame shown in FIG.21, but shown without the tracking probe according to embodiments of thepresent invention.

FIG. 25A is an enlarged side perspective view of a bottom portion of thetrajectory frame shown in FIG. 21 illustrating exemplary attachmentconfigurations according to embodiments of the present invention.

FIG. 25B is a greatly enlarged partial bottom perspective view of thebracket shown in FIG. 25A.

FIG. 26A is a top perspective view of an exemplary bracket for attachinga reference frame to the trajectory frame according to embodiments ofthe present invention.

FIG. 26B is an assembled view of the bracket shown in FIG. 26A toattachment segments of the trajectory guide according to embodiments ofthe present invention.

FIG. 27A is a side perspective view of another exemplary attachmentbracket according to embodiments of the present invention.

FIG. 27B is an enlarged partial assembly view of a portion of aconnector attached to the reference frame bracket shown in FIG. 27A,assembled to an attachment segment of the trajectory frame according toembodiments of the present invention.

FIG. 27C is an enlarged partial assembly view of the reference frameattachment bracket shown in FIG. 27A according to embodiments of thepresent invention.

FIG. 28 is a side perspective view of the trajectory frame shown inFIGS. 21 and 22 illustrating the support column releasably holding amicroelectric (MER) probe drive adapter, typically for awake deep brainsurgeries, according to embodiments of the present invention.

FIG. 29A is a side perspective view of the MER probe drive adapter shownin FIG. 28 according to embodiments of the present invention.

FIG. 29B is a partial exploded view of the MER probe drive adapter andtrajectory frame shown in FIG. 29A according to embodiments of thepresent invention.

FIG. 30 is a side perspective view of a trajectory frame holding a probedriver using the MER probe driver adapter shown in FIGS. 28, 29A, 29B,according to embodiments of the present invention.

FIG. 31A is a side perspective view of a trajectory frame holding auniversal tracker according to embodiments of the present invention.

FIG. 31B is a side/front view of the assembly shown in FIG. 31A.

FIG. 31C is a front view of a tracker guide holding the universaltracker for releasable attachment to a support column/guide of thetrajectory frame according to embodiments of the present invention.

FIG. 31D is a front view of the tracker guide without the universaltracker shown in FIGS. 31A-C according to embodiments of the presentinvention.

FIG. 32 is a side view of a trajectory frame illustrating the trackingguide shown in FIGS. 31A-31D, replaced by a device (DBS lead) guideaccording to embodiments of the present invention.

FIG. 33 is a schematic illustration of a camera-based navigation systemaccording to embodiments of the present invention.

FIG. 34A is a schematic illustration of a trajectory frame with an EMtracking probe according to embodiments of the present invention.

FIG. 34B is a schematic illustration of a tracking probe with acooperating mount to attach to the trajectory frame shown in FIG. 34Aaccording to embodiments of the present invention.

FIG. 35 is a schematic illustration of an EM-based navigation systemaccording to embodiments of the present invention.

DETAILED DESCRIPTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which some embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, thethickness of certain lines, layers, components, elements or features maybe exaggerated for clarity.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising”, when used in this specification, specify thepresence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on”, “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if the device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of “over” and “under”. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

The term “about”, as used herein with respect to a value or number,means that the value or number can vary by +/−twenty percent (20%).

The term “MRI visible” means that a device is visible, directly orindirectly, in an MRI image. The visibility may be indicated by theincreased SNR of the MRI signal proximate to the device (the device canact as an MRI receive antenna to collect signal from local tissue)and/or that the device actually generates MRI signal itself, such as viasuitable hydro-based coatings and/or fluid (typically aqueous solutions)filled channels or lumens.

The term “MRI compatible” means that a device is safe for use in an MRIenvironment and/or can operate as intended in an MRI environment withoutgenerating MR signal artifacts, and, as such, if residing within thehigh-field strength region of the magnetic field, is typically made of anon-ferromagnetic MRI compatible material(s) suitable to reside and/oroperate in a high magnetic field environment.

The term “high-magnetic field” refers to field strengths above about 0.5T (Tesla), typically above 1.0 T, and more typically between about 1.5 Tand 10 T.

The term “targeting cannula” refers to an elongate device, typicallyhaving a substantially tubular body that can be oriented to providepositional data relevant to a target treatment site and/or define adesired access path orientation or trajectory. At least portions of atargeting cannula contemplated by embodiments of the invention can beconfigured to be visible in an MRI image, thereby allowing a clinicianto visualize the location and orientation of the targeting cannula invivo relative to fiducial and/or internal tissue landscape features.

The term “cannula” refers to an elongate device that can be associatedwith a trajectory frame that attaches to a patient, but does notnecessarily enter the body of a patient.

The term “imaging coils” refers to a device that is configured tooperate as an MRI receive antenna. The term “coil” with respect toimaging coils is not limited to a coil shape but is used generically torefer to MRI antenna configurations, loopless, looped, etc., as areknown to those of skill in the art. The term “fluid-filled” means thatthe component includes an amount of the fluid but does not require thatthe fluid totally, or even substantially, fill the component or a spaceassociated with the component. The fluid may be an aqueous solution, MRcontrast agent, or any material that generates MRI signal.

The term “two degrees of freedom” means that a trajectory framedescribed herein allows for at least translational (swivel or tilt) androtational movement over a fixed site, which may be referred to as aRemote Center of Motion (RCM).

The terms “ACPC coordinate space” or “AC-PC orientation” refers to aright-handed coordinate system defined by anterior and posteriorcommissures (AC, PC) and Mid-Sagittal plane points, with positivedirections corresponding to a patient's anatomical Right, Anterior andHead directions with origin at the mid-commissure point.

Embodiments of the present invention can be configured to guide and/orplace diagnostic or interventional devices and/or therapies to anydesired internal region of the body or object using MRI and/or in an MRIscanner or MRI interventional suite or using other image guided systemsnot requiring an MRI system or suite.

The object can be any object, and may be particularly suitable foranimal and/or human subjects. Some embodiments can be sized andconfigured to place implantable DBS leads for brain stimulation,typically deep brain stimulation. Some embodiments can be configured todeliver tools or therapies that stimulate a desired region of thesympathetic nerve chain. Other uses inside or outside the brain includestem cell placement, gene therapy or drug delivery for treatingphysiological conditions. Some embodiments can be used to treat tumors.Some embodiments can be used for RF ablation, laser ablation, cryogenicablation, etc.

In some embodiments, the trajectory frame and/or interventional toolscan be configured to facilitate high resolution imaging via integralintrabody imaging coils (receive antennas), high intensity focusedultrasound (HIFU), and/or the interventional tools can be configured tostimulate local tissue, which can facilitate confirmation of properlocation by generating a physiologic feedback (observed physicalreaction or via fMRI).

Some embodiments can be used to deliver bions, stem cells or othertarget cells to site-specific regions in the body, such as neurologicaltarget sites and the like. In some embodiments, the systems deliver stemcells and/or other cardio-rebuilding cells or products into cardiactissue, such as a heart wall via a minimally invasive image guidedprocedure, while the heart is beating (i.e., not requiring a non-beatingheart with the patient on a heart-lung machine). Examples of knownstimulation treatments and/or target body regions are described in U.S.Pat. Nos. 6,708,064; 6,438,423; 6,356,786; 6,526,318; 6,405,079;6,167,311; 6,539,263; 6,609,030 and 6,050,992, the contents of which arehereby incorporated by reference as if recited in full herein.

Generally stated, some embodiments of the invention are directed tointerventional procedures and provide interventional tools and/ortherapies that may be used to locally place interventional tools ortherapies in vivo to site-specific regions using an image guided system.The interventional tools can be used to define a trajectory or accesspath to an in vivo treatment site. Some embodiments of the inventionprovide interventional tools that can provide positional data regardinglocation and orientation of a tool in 3-D space with a visualconfirmation on an image. Embodiments of the invention may provide anintegrated system or trajectory frames and components that can be usedwith one or more of commercially available conventional image guidedsystems that may allow physicians to place interventional devices/leadsand/or therapies accurately.

Some embodiments configure devices so that they are compatible withseveral imaging modalities and/or image-guided systems.

For MRI uses, the systems may allow for shorter duration procedures overconventional systems (typically under six hours for DBS implantationprocedures, such as between about 1-5 hours).

In some embodiments, a pre-operative image such as an MRI image can beused to visualize (and/or locate) a therapeutic region of interestinside the brain or other body locations. During surgery, the MRI orother pre-operative image can be used to visualize (and/or locate) aninterventional tool or tools that will be used to deliver therapy and/orto place a chronically implanted device that will deliver therapy.

In some embodiments, the three-dimensional data produced by anMRI-guided interventional system regarding the location of thetherapeutic region of interest and the location of the interventionaltool can allow the system and/or physician can make positionaladjustments to the interventional tool so as to align the trajectory ofthe interventional tool with the region of interest, so that wheninserted into the body, the interventional tool will intersect with thetherapeutic region of interest.

In some embodiments, a camera based tracking system can be used.

The IGS systems can have a hardware component and a software component.In some embodiments, the hardware component includes a camera andworkstation that can be used for many applications such as cranial,spine, orthopedic, ENT. There can be different software packages ormodules for each system for each application.

When the MRI system and/or the camera based image guided system confirmsalignment is proper, the interventional tool aligned with thetherapeutic region of interest, an interventional probe can be advanced,such as through an open lumen inside of the interventional tool, so thatthe interventional probe follows the trajectory of the interventionaltool and proceeds to the therapeutic region of interest. It should benoted that the interventional tool and the interventional probe may bepart of the same component or structure. A sheath may optionally formthe interventional tool or be used with an interventional probe or tool.

In particular embodiments, using MRI in combination with local orinternal imaging coils and/or MRI contrast material that may becontained at least partially in and/or on the interventional probe orsheath, the location of the interventional probe within the therapeuticregion of interest can be visualized on a display or image and allow thephysician to either confirm that the probe is properly placed fordelivery of the therapy (and/or placement of the implantable device thatwill deliver the therapy) or determine that the probe is in theincorrect or a non-optimal location. Assuming that the interventionalprobe is in the proper desired location, the therapy can be deliveredand/or the interventional probe can be removed and replaced with apermanently implanted therapeutic device at the same location.

In some embodiments, in the event that the physician determines from theMRI image produced by the MRI and the imaging coils, which mayoptionally be contained in or on the interventional probe, that theinterventional probe is not in the proper location, a new therapeutictarget region can be determined from the MRI images, and the system canbe updated to note the coordinates of the new target region. Theinterventional probe is typically removed (e.g., from the brain) and theinterventional tool can be repositioned so that it is aligned with thenew target area. The interventional probe can be reinserted on atrajectory to intersect with the new target region. Although describedand illustrated herein with respect to the brain and the insertion ofdeep brain stimulation leads, it is understood that embodiments of thepresent invention may be utilized at other portions of the body and forvarious other types of procedures.

Embodiments of the present invention will now be described in detailbelow with reference to the figures. FIG. 1A is a block diagram of anMRI-guided interventional system 50, according to some embodiments ofthe present invention. The illustrated system 50 includes an MRI scanner75, a trajectory frame 100 attached to the body of a patient positionedwithin a magnetic field B₀ of the MRI scanner 75, a remote control unit400, a trajectory guide software module 300, and a clinician display500. The trajectory frame 100 is configured to support various devicesincluding a targeting cannula through which various interventionaldevices may be inserted into the body of a patient. The frame 100 isadjustable such that the targeting cannula is rotatable about a pitchaxis, about a roll axis, and such that the targeting cannula cantranslate in X-Y directions relative to a Z-direction defined by a guideconfigured to support devices such as a targeting cannula. The frame 100may be attached to the body of a patient directly or indirectly and maybe configured to be attached to various parts of the body.

FIG. 33 illustrates an image-guided system that can be used for non-MRIimage guided systems. The trajectory frame 1100 and some or all of itscooperating components may be configured to be compatible for use in MRIand CT and/or camera C based image guided systems “S.” In someembodiments, separate versions of the trajectory frame 1100 and some orall cooperating components may be provided as CT and/or camera basedconfigurations that may use different materials or components. Forexample, a camera guided system C does not require a targeting cannula200 but instead can use a tracking probe, e.g., 1162 (FIG. 21) oruniversal tracker 1190 (FIG. 31A) or an EM navigation system 10EM withan EM probe 1500 (FIG. 34A/35).

To be clear, the term “image guided system” is used generally to referto surgical navigation systems that include displays with patient images(which may be acquired before a surgery and/or at defined points duringa surgery to confirm location) but does not require a continuous seriesof images from an imaging modality, such as a CT or MRI scanner, duringthe surgery.

In some embodiments, a remote control unit 400 is provided to allow auser to remotely adjust the position of the targeting cannula or otherdevices supported by the trajectory frame 100. The system 50 can includea trajectory guide software module 300 that allows a user to define andvisualize, via display 500, a desired trajectory (D, FIGS. 1B, 11-12)into the body of a patient of an interventional device extending throughthe targeting cannula. The trajectory guide software module 300 alsoallows the user to visualize and display, via display 500, an actualtrajectory (A, FIG. 11) into the body of an interventional deviceextending through the targeting cannula. The trajectory guide softwaremodule 300 displays to the user positional adjustments (FIG. 1B) (e.g.,pitch axis rotation, roll axis rotation, X-Y translation) needed toalign the actual trajectory of the targeting cannula with the desiredtrajectory path. In addition, the user can view, via display 500, theactual trajectory changing as he/she adjusts the position of thetargeting cannula. The trajectory guide software module 300 can beconfigured to indicate and display when an actual trajectory is alignedwith a desired trajectory.

In some embodiments, the trajectory guide software module can be anoff-the-shelf module provided with conventional image guided systemsthat does not require any (or insignificant) modification. That is, thetrajectory frame 1100 (FIG. 21) can be configured to accommodatedefined, conventional shapes of optical fiducial components, e.g., 4spheres or 3 spheres in a defined array orientation 1204 a, 1164 a, 1194a, of reference tracking frames 1200 (FIG. 22) and/or tracking probes1162, 1190 (FIG. 22, 31A). Examples of known commercial systems withtrajectory guide software modules for camera based image guided systemsthat can be used with configurations of the trajectory frames andcooperating components include, for example systems from Brainlab, Inc.,Stryker Medical and Medtronic Inc.

The IGS systems have a hardware and software component. The hardwarecomponent includes a camera and workstation can be used for manyapplications such as cranial, spine, orthopedic, ENT. There can bedifferent software packages or modules for each system for eachapplication. For example, one Medtronic system includes the StealthStation as a hardware component and the software is called Framelink®.Medtronic, Inc. (Minneapolis, Minn.) also has a Nexframe® stereotacticimage guided system.

Examples of Stryker's navigation systems include the Navigation SystemII, the eNlite Navigation System, and a seamlessly integrated NavSuiteOperating Room. Brainlab systems include the Curve™ Image Guided Surgerysystem is a command and control system for information-guided surgery.Brainlab also offers Kick® Purely Navigation software control witheither optical or electromagnetic (EM) tracking as well as Dash® DigitalCutting Block Alignment as a software-guided cutting block alignmenttool, Airo® Mobile Intraoperative CT intended for the O.R. and Buzz™Digital O.R. which displays and enhances DICOM images.

FIG. 2A illustrates a burr hole 10 formed in the skull S of a patient. Aburr hole ring 12 overlies the burr hole 10 and is secured to the skullS. The illustrated burr hole ring 12 has at least one pair of ears 14,each ear configured to receive a respective fastener (e.g., screw)therethrough for securing the burr hole ring 12 to the skull. In theillustrated embodiment, the burr hole ring 12 is secured to the skull Svia screws 16.

FIG. 2B illustrates an optional removable centering device 18 positionedon the burr hole ring 12. The centering device 18 includes slots,channels, or other recessed or cut out portions 20 that fit over theears 14 of the burr hole ring 12. The function of the centering device18 is to facilitate centering a trajectory frame 100, described below,over the burr hole 10. After the trajectory frame 100 is attached to theskull of a patient, the centering device 18 is removed.

Referring to FIG. 3A, a trajectory frame 100 (which can also bedescribed interchangeably as a “trajectory guide”) is shown. Thetrajectory frame 100 may be configured to releasably hold a targetingcannula 200 as illustrated. The trajectory frame 100 includes a guide204 (shown in partial view for ease of illustration), such as a supportcolumn, that removably receives the targeting cannula 200 (and/or othercomponents) therein. The guide 204 (or guide/support column 1102 (e.g.,FIG. 21 et seq.) can be secured to the X-Y support table 132 of thetrajectory frame 100 (or 1100, FIG. 21, et seq.). The guide 204/1102defines a Z-direction along its longitudinal axis relative to the X-Yplane of the X-Y support table 132. The trajectory frame 100 allows forthe adjustability (typically at least two degrees of freedom, includingrotational and translational) and/or calibration/fixation of thetrajectory of a device held therein (e.g., as shown, in FIG. 3A, thetargeting cannula 200 and/or probe or tool inserted through thetargeting cannula 200).

For MRI-image guided versions of the system, the targeting cannula 200can include an axially-extending guide bore 201 (FIG. 8B) therethroughthat is configured to guide the desired therapeutic or diagnostic tool,e.g., intra-brain placement of a stimulation lead (or other type ofdevice) in vivo, as will be described below. Intra-brain placement ofdevices may include chronically placed devices and acutely placeddevices. Again, for MRI-image guided systems, the trajectory frame 100may include fiducial markers 117 that can be detected in an MRI tofacilitate registration of position in an image. For non-MRI uses, theMRI-type fiducial markers 117 are not required.

The illustrated trajectory frame 100 is configured to be mounted to apatient's skull around a burr hole ring (12, FIG. 1A) and over a burrhole (10, FIG. 1A), to provide a stable platform for advancing surgicaldevices, leads, etc. in the brain. The trajectory frame 100 includes abase 110, a yoke 120, a platform 130, and a plurality of actuators 140a-140 d. The base 110 has a patient access aperture 112 formed therein,as illustrated. The base 110 is configured to be secured (directly orindirectly) to the skull of a patient such that the patient accessaperture 112 overlies the burr hole 10 in the patient skull. The patientaccess aperture 112 can be centered over the burr hole 10 via theremovable centering device 18.

The yoke 120 is movably mounted to the base 110 and is rotatable about aroll axis RA. A roll actuator 140 a is operably connected to the yoke120 and is configured to rotate the yoke 120 about the roll axis RA, aswill be described in detail below. In some embodiments, the yoke 120 hasa range of motion about the roll axis RA of about seventy degrees)(70°.However, other ranges, greater and lesser than 70°, are possible, e.g.,any suitable angle typically between about 10°-90°, 30°-90°, etc. Theillustrated platform 130 is movably mounted to the yoke 120 and isrotatable about a pitch axis PA. A pitch actuator 140 b is operablyconnected to the platform 130 and is configured to rotate the platform130 about the pitch axis PA. In some embodiments, the platform 130 has arange of motion about the pitch axis PA of about seventy degrees)(70°.However, other ranges, greater and lesser than 70°, are possible, e.g.,any suitable angle typically between about 10°-90°, 30°-90°, etc.

The illustrated platform 130 includes an X-Y support table 132 that ismovably mounted to the platform 130. The X-Y support table 132 isconfigured to move in an X-direction and Y-direction relative to theplatform 130 and relative to a Z-direction defined by the longitudinalaxis of the guide 204 and/or 1102. An X-direction actuator 140 c isoperably connected to the platform 130 and is configured to move the X-Ysupport table 132 in the X-direction. A Y-direction actuator 140 d isoperably connected to the platform 130 and is configured to move the X-Ysupport table 132 in the Y-direction. A pitch actuator 140 b is operablyconnected to the platform 130 and is configured to rotate the platform130 about the pitch axis PA.

The actuators 140 a-140 d are configured to translate and/or rotateportions of the trajectory frame 100. The targeting cannula 200 and/ortracking probe 1162/1194 (FIGS. 21, 31A) can be configured to translatein response to translational movement of the X-Y support table 132 andto rotate in response to rotational movement of the yoke 120 andplatform 130 to define different axial intrabody trajectories extendingthrough the patient access aperture 112 in the frame base 110.

The actuators 140 a-140 d may be manually-operated devices, such asthumbscrews, in some embodiments. The thumbscrews can be mounted on theframe 100 or may reside remotely from the frame 100. A user may turn theactuators 140 a-140 d by hand to adjust the position of the frame 100and, thereby, a trajectory of the targeting cannula 200. In otherembodiments, the actuators 140 a-140 d are operably connected to aremote control unit 400 (FIG. 1A) via a respective plurality of(optionally non-ferromagnetic when used for non-MRI systems), flexibledrive shafts or control cables 150 a-150 d (FIG. 3A). The remote controlunit 400 (FIG. 1A) includes a plurality of position controls, and eachcable 150 a-150 d is operably connected to a respective position controland to a respective actuator 140 a-140 d. Movement of a position controloperates a respective actuator 140 a-140 d via a respective controlcable 150 a-150 d. The cables 150 a-150 d may extend a suitable distance(e.g., between about 1-4 feet, etc.) to allow a clinician to adjust thesettings on the trajectory frame 100 without moving a patient and from aposition outside the bore of a magnet (where a closed bore magnet typeis used or where an MRI image guided system is used) associated with anMRI scanner.

FIGS. 3B-3E are schematic side view sequential illustrations of thetrajectory frame 100 being secured to the skull of a patient. FIG. 3Billustrates use of the centering device 18 to align the frame 100relative to the burr hole 10. In FIG. 3C, the frame 100 is secured tothe skull with fasteners and such that the patient access aperture 112in the base 110 is centered around the centering device 18. In FIG. 3D,the yoke 120 is rotated out of the way such that the centering device 18can be removed. In FIG. 3E, the targeting cannula 200 is moved to anextended position and locked in the extended position via prongs 208that engage slots 1103 in the guide 204. FIG. 21 illustrates a similarextended configuration for the tracking probe 1160 for image guidedsystems that are not required to use (and typically do not use) thetargeting cannula 200.

Referring to FIGS. 6-7, the base 110 includes a plurality of locations110 a for attaching the base 110 to a skull of a patient via fasteners17. Each location 110 a may include two or more adjacent apertures 114.Each aperture 114 is configured to receive a fastener 17 (e.g., a screw,rod, pin, etc.) therethrough that is configured to secure the base 110to the skull of a patient. The base can be a scalp mount or skull mounttype base 110.

The base 110 can includes MRI-visible fiducial markers 117 that allowthe location/orientation of the trajectory frame 100 to be determinedwithin an MRI image during an MRI-guided procedure. In the illustratedembodiment, the fiducial markers 117 have a torus or “doughnut” shapeand are spaced apart. However, fiducial markers having various shapesand positioned at various locations on the trajectory frame 100 may beutilized. For non-MRI uses, the fiducials 117 can be omitted.

The base 110 also includes a pair of spaced apart arcuate arms 116, asillustrated in FIG. 9. The yoke 120 (FIG. 3A) is pivotally attached topivot points 113 (FIG. 9) for rotation about the roll axis RA. The yoke120 engages and moves along the base arcuate arms 116 when rotated aboutthe roll axis RA. In the illustrated embodiment, one of the base arcuatearms 116 includes a thread pattern 118 formed in (e.g., embossed within,machined within, etc.) a surface 116 a thereof. However, in otherembodiments, both arms 116 may include respective thread patterns. Theroll actuator 140 a includes a rotatable worm 142 with teeth that areconfigured to engage the thread pattern 118, as illustrated in FIG. 5.As the worm 142 is rotated, the teeth travel along the thread pattern118 in the arcuate arm surface 116 a. Because the base 110 is fixed to apatient's skull, rotation of the roll actuator worm 142 causes the yoke120 to rotate about the roll axis RA relative to the fixed base 110.Rotation about roll axis RA is illustrated in FIGS. 4-5. For example, inFIG. 5, the yoke 120 is rotated about the roll axis RA sufficiently toallow access to and removal of the optional centering device 18.

Referring to FIG. 10, the yoke 120 includes a pair of spaced apartupwardly extending, arcuate arms 122. The platform 130 engages and movesalong the yoke arcuate arms 122 when rotated about the pitch axis PA. Inthe illustrated embodiment, one of the yoke arcuate arms 122 includes athread pattern 124 formed in (e.g., embossed within, machined within,etc.) a surface 122 a thereof. However, in other embodiments, both arms122 may include respective thread patterns. The pitch actuator 140 bincludes a rotatable worm 146 with teeth 148 that are configured toengage the thread pattern 124. As the worm 146 is rotated, the teeth 148travel along the thread pattern 124 in the arcuate arm surface 122 a.Because the base 110 is fixed to a patient's skull, rotation of thepitch actuator worm 146 causes the platform 130 to rotate about thepitch axis PA relative to the fixed base 110.

As illustrated in FIG. 3A, the roll actuator 140 a, pitch actuator 140b, X-direction actuator 140 c, and Y-direction actuator 140 d eachextend outwardly from the frame 100 along substantially the samedirection (e.g., upwardly from the platform 130). This configurationfacilitates easy connection of the control cables 150 a-150 d to theactuators 140 a-140 d (where used) and also facilitates bundling of thecables 150 a-150 d to reduce clutter or provide ease of handling andset-up. Embodiments of the present invention are not limited to theorientation/arrangement of the actuators 140 a-140 d and cables 150a-150 d, however. The actuators 140 a-140 d may extend in variousdirections and these directions may be different from each other. Inaddition, the actuators 140 a-140 d may extend along the same directionfrom the frame, but in a different direction than that illustrated inFIG. 3A.

Operations associated with a typical MRI-image guided surgical procedureusing the trajectory frame 100, according to some embodiments of thepresent invention, will now be described. These operations relate todeep brain stimulation procedures. Embodiments of the present inventionare not limited to use with deep brain stimulation procedures, however,nor are the devices limited to MRI-image guided procedures.

Initially, a patient is placed within an MR scanner and MR images areobtained of the patient's head that visualize the patient's skull,brain, fiducial markers and ROI (region of interest or targettherapeutic site). The MR images can include volumetric high-resolutionimages of the brain. To identify the target ROI, certain knownanatomical landmarks can be used, i.e., reference to the AC, PC and MCPpoints (brain atlases give the location of different anatomies in thebrain with respect to these points) and other anatomical landmarks. Thelocation of a burr hole 10 (FIG. 2A) may optionally be determinedmanually by placing fiducial markers on the surface of the head orprogrammatically by projecting the location in an image.

Images in the planned plane of trajectory are obtained to confirm thatthe trajectory is viable, i.e., that no complications with anatomicallysensitive areas should occur. The patient's skull is optically ormanually marked in one or more desired locations to drill the burr hole.The burr hole 10 is drilled and a burr hole ring 12 is affixed to theskull overlying the burr hole.

The trajectory frame 100 is then fixed to the skull of the patient andthe targeting cannula 200 is properly fitted thereto. A localizationscan can be obtained to determine/register the location of the targetingcannula 200, in direct orientation of the trajectory frame 100. Thesettings to which the trajectory frame 100 should be adjusted areelectronically determined so that the targeting cannula 200 is in thedesired trajectory plane. Frame adjustment calculations are provided toa clinician who can manually or electronically adjust the orientation ofthe trajectory frame 100. The desired trajectory plane is confirmed byimaging in one or more planes orthogonal to the desired trajectoryplane.

Once the targeting cannula 200 has the desired trajectory plane, amultipurpose probe (not shown) and delivery sheath (not shown) can beadvanced through the targeting cannula 200. The advancement of the probecan be monitored by imaging to verify that the probe will reach thetarget accurately. If the probe and delivery sheath are at the desiredtarget, the sheath is left in place and the probe is removed. The sheathcan now act as the delivery cannula for an implantable lead (not shown).

If the probe and delivery sheath are not at the desired/optimallocation, a decision is made as to where the probe and delivery sheathneed to be. The trajectory frame 100 is adjusted accordingly via theactuators 140 a-140 d and the probe and delivery sheath are re-advancedinto the brain. Once the probe and delivery sheath are at the desiredlocation, the probe is removed and the delivery sheath is left in place.A lead is then advanced to the target location using the sheath as aguide. The location of the lead is confirmed by reviewing an image,acoustic recording and/or stimulation. The sheath is then removed,leaving the lead in place.

It is contemplated that embodiments of the invention can provide anintegrated system 50 that may allow the physician to place theinterventional device/leads accurately and in short duration of time. Insome embodiments, once the burr hole is drilled, and the trajectoryframe is fixed to the skull; the trajectory frame is oriented such thatthe interventional device advanced using the trajectory frame followsthe desired trajectory and reaches the target as planned in preoperativesetup imaging plans. As described herein, the system 50 can employhardware and software components to facilitate an automated orsemiautomated operation to carry out this objective.

Referring now to FIGS. 13-19, a trajectory frame 1100, according toembodiments of the present invention, is illustrated. The trajectoryframe 1100 is similar to the trajectory frame 100 described above withrespect to FIGS. 1A-12, but is configured to removably receive a devicesof various sizes and configurations within a support column or guide1102 (similar to guide 204), as described below. The illustratedtrajectory frame 1100 is configured to be mounted to a patient's skullaround a burr hole ring (12, FIG. 1) and over a burr hole (10, FIG. 1),to provide a stable platform for advancing surgical devices, leads,etc., in the brain, as described above. However, a trajectory frame 1100according to embodiments of the present invention can be configured tobe mounted to various portions of the body of a patient.

Again, as for the similar trajectory frame 100 described above, theillustrated trajectory frame 1100 includes a base 110, a yoke, 120, aplatform 130, and a plurality of actuators 140 a-140 d. The base 110 hasa patient access aperture 112 formed therein, as illustrated. The base110 is configured to be secured (directly or indirectly) to the skull orscalp of a patient such that the patient access aperture 112 overliesthe burr hole 10 in the patient skull. The base 110 can include aplurality of narrow, tapered members 19 that can be driven into theskull of a patient to prevent the base 110 from moving. Fasteners 17,such as screws, can then used to secure the base to the skull of thepatient, as described above.

The patient access aperture 112 is configured to be centered over a burrhole 10 optionally via a removable centering device 18, as describedabove. The yoke 120 is movably mounted to the base 110 and is rotatableabout a roll axis RA, as described above. The platform 130 is movablymounted to the yoke 120 and is rotatable about a pitch axis PA, asdescribed above.

The illustrated platform 130 includes an X-Y support table 132 that ismovably mounted to the platform 130. The X-Y support table 132 isconfigured to move in an X-direction and Y-direction relative to theplatform 130 and to a Z-direction defined by the longitudinal axis ofthe guide 1102. An X-direction actuator 140 c is operably connected tothe platform 130 and is configured to move the X-Y support table 132 inthe X-direction. A Y-direction actuator 140 d is operably connected tothe platform 130 and is configured to move the X-Y support table 132 inthe Y-direction. A pitch actuator 140 b is operably connected to theplatform 130 and is configured to rotate the platform 130 about thepitch axis PA.

The actuators 140 a-140 d are configured to translate and/or rotate theframe. When inserted within the guide 1102, the targeting cannula 200,tracking probe 1160 or 1190 (FIG. 21, 31A) and other devices insertedwithin the guide 1102, are configured to translate in response totranslational movement of the X-Y support table 132 and to rotate inresponse to rotational movement of the yoke 120 and platform 130 todefine different axial intrabody trajectories extending through thepatient access aperture 112 in the frame base 110.

The trajectory frame guide 1102 is configured to removably receivevarious probes and/or tools, as described below. For example, the guide1102 may have a larger diameter than conventional targeting cannulaguides which, thereby allows for various devices to be utilized with theframe 1100 that otherwise would not be able to do so.

In addition, guides 1102 having different size internal diameters may beprovided for receiving various devices of different sizes or a singleguide 1102 can be integral to the frame 1100 and configured to receivedifferent tools having different diameters. If the former, for example,a guide 1102 may have an internal diameter sized to receive a particulardevice therein. Another guide 1102 may have a larger or smaller internaldiameter also sized to receive a particular device therein. Tofacilitate replacing one size guide 1102 with another, each guide 1102may be removably and interchangeable secured to the X-Y support table132. For example, each guide may be threadingly secured to the X-Ysupport table 132. However, other means for removably securing a guide1102 to the X-Y support table 132 can be utilized.

The trajectory frame 1100 allows for the adjustability (typically atleast two degrees of freedom, including rotational and translational)and calibration/fixation of the trajectory of at least one of, andtypically all of, a targeting cannula 200, and a tracking probe 1160,1190 (FIG. 21, 31A) and/or other probe or tool inserted through the or arespective guide 1102.

The removable targeting cannula 200 has a proximal end portion 200 a, anopposite distal end portion 200 b, and an axially-extending guide bore201 extending from the proximal end portion 200 a to the distal endportion 200 b that is configured to guide a therapeutic or diagnostictool, e.g., intra-brain placement of a stimulation lead (or other typeof device) in vivo. Intra-brain placement of devices may includechronically placed devices and acutely placed devices. The trajectoryframe 1100 may optionally include fiducial markers 117 (MRI detectablefiducials when used for MRI-image guided systems) that can be detectedin an MRI to facilitate registration of position in an image. Lugs 208extend outwardly from the proximal end portion 200 a of the targetingcannula 200. These lugs 208 are configured to removably secure thetargeting cannula 200 to the guide 1102. Other cooperating devices forthe trajectory frame 1100 may also have lugs, e.g., 1168 (FIG. 21,23A-C), 1178 (FIGS. 29A-C) and 1198 (FIGS. 31A-C), for attachment to theguide 1102 or an interchangeable respective guide 1102 held by theplatform 130, and are not required to be MRI-compatible as they may beused for non-MRI surgical image/camera tracking and/or guided systems.

The guide 1102 has opposite proximal and distal end portions 1102 a,1102 b. In some embodiments, the proximal end portion 1102 a containsthreads 1104, as illustrated. These threads 1104 can be molded ormachined into the guide 1102, as would be understood by those skilled inthe art of the present invention.

The threads 1104 can be configured to threadingly engage acorrespondingly threaded cap 1106 to secure a targeting cannula 200 andother devices within the guide 1102, and to allow for quick removal.FIG. 14 illustrates the targeting cannula 200 within the guide 1102 andthe cap 1106 threadingly secured to the threads 1104 of the guideproximal end portion 1102 a. The illustrated cap 1106 includes anopening 1106 a to facilitate insertion of a probe or other device intoand through the lumen 201 of the targeting cannula 200.

In other embodiments, the guide proximal end portion 1102 a may includea detent (not shown) or similar structure formed therein and the cap1106 may include a protrusion (not shown) configured to engage thedetent so as to removably secure the cap 1106 and targeting cannula 200to the guide 1102 (i.e., create a “snap fit”) and to allow for quickremoval. Alternatively, the guide proximal end portion 1102 a mayinclude a protrusion extending therefrom and the cap 1106 may include adetent formed therein that is configured to engage the protrusion so asto removably secure the cap and targeting cannula 200 to the guide 1102.In addition, various other ways of causing frictional engagement (e.g.,an interference fit) may be utilized for removably securing the cap 1106and targeting cannula 200 to the guide 1102 and to allow for quickremoval, without limitation. Various shapes and/or components that allowfor quick removal may be utilized, without limitation.

In some embodiments, the targeting cannula 200 and cap 1106 can be apreassembled unit.

The guide 1102 includes downwardly extending slots 1103, shown as a pairof opposing slots 1103, formed in the proximal end portion 1102 a,thereof, as illustrated. Each slot 1103 includes an upper ledge portion1103 a and a lower ledge portion 1103 b that are configured to engagethe targeting cannula lugs 208. The lugs 208 cooperate with the slots1103 to allow the targeting cannula 200 to be inserted within the guide1102. By rotating the targeting cannula 200 such that the lugs 208cooperate with the upper ledge portions 1103 a, the targeting cannula200 can be positioned at a first or upper position. By inserting thetargeting cannula 200 further within the guide 1102 and then rotatingthe targeting cannula 200 such that the lugs 208 cooperate with thelower ledge portions 1103 a, the targeting cannula 200 can be securelyheld at a second or lower position.

Typically after the trajectory frame 1100 is aligned, a center punch(not shown) can be placed down the targeting cannula lumen 201 andpushed or tapped into the skull of a patient. This will create anincision in the scalp and provide a starting point for a drill bit.Alternately, an incision can be made in a patient's scalp first. In someinstances, a center punch may not be required.

FIG. 15A illustrates the trajectory frame 1100 of FIG. 13 with thetargeting cannula 200 removed from the guide 1102 and wherein the guide1102 is configured to removably receive a drill guide 1110 and longdrill bit 1112 inserted therewithin. FIG. 15B illustrates the drillguide 1110 of FIG. 15A inserted within the guide 1102 and a threaded cap1114, having an opening 1114 a, of the drill guide threadingly securedto the threads 1104 at the proximal end portion 1102 a of the guide1102. Alternatively, the cap 1114 of the drill guide may be attached tothe guide proximal end 1102 a via a detent or other similar structure,as described above. Once a hole is drilled in the skull of a patient viathe drill bit 1112, the drill bit 1112 and drill guide 1110 are removed.Note that a drill guide 1110 and drill bit 1112 may not be required ifan access (burr) hole is already made within the skull.

FIGS. 16A-16B and 17 illustrate the trajectory frame 1100 of FIG. 13with the targeting cannula 200 removed from the guide 1102 and whereinthe guide 1102 is configured to removably receive a skull fixationdevice driver 1120 inserted through the proximal end portion 1102 athereof. A skull fixation device 1122 is inserted in the guide distalend 1102 b. The skull fixation device 1122 and the skull fixation devicedriver 1120 are configured to be engaged such that the skull fixationdevice 1122 can be screwed into the skull of a patient by rotating andadvancing the skull fixation device driver 1120 from the proximal end1102 a of the guide 1102. The illustrated skull fixation device driver1120 is provided with a knob or handle 1124 that facilitates rotation ofthe skull fixation device driver 1120 by hand.

As shown in FIGS. 18A-18B, after the skull fixation device 1122 isattached to the skull of a patient, the skull fixation device driver1120 is removed from the guide 1102 and a catheter guide 1130 may beinserted within the guide 1102 through the proximal end 1102 a thereof.The catheter guide 1130 includes a cap 1132 secured to a proximal end1130 a thereof that is threaded and configured to be threadingly securedto the threaded proximal end portion 1102 a of the guide 1102.Alternatively, the cap 1132 of the catheter guide 1130 may be attachedto the guide proximal end 1102 a via a detent, interference fit, or viavarious other types of frictional engagement, and via various shapesand/or components that allow for quick removal, without limitation.

The illustrated cap 1132 includes an opening 1132 a to facilitateinsertion of a probe or other device into and through the lumen 201 ofthe targeting cannula 200. FIG. 19 illustrates a catheter 1140 or otherdevice advanced through the catheter guide 1130 via a tool 1150.

Referring now to FIGS. 20A-20B, as shown, the trajectory frame 1100 hasa proximal end portion 1102 a that does not include a threaded proximalend portion 1102 a. Various devices inserted within the guide 1102, suchas the illustrated targeting cannula 200 can be removably secured to theguide via lugs, such as targeting cannula lugs 208, that cooperate withelongated slots 1103 in the guide 1102. The elongated slots 1103 mergeinto spaced-apart transversely extending upper ledge portions (e.g.,slots) 1103 a and transversely extending lower ledge portions (e.g.,slots) 1103 b. The distance between the upper ledge portions 1103 a andthe lower edge portions 1103 b is typically between about 0.25 inchesand about 5.0 inches.

By rotating a device within the guide 1102 such that the lugs, forexample the targeting cannula lugs 208, cooperate with the upper ledgeportions 1103 a, a device can be securely held at a first or upperposition. By inserting the device further within the guide 1102 and thenrotating the device such that the lugs cooperate with the lower ledgeportions 1103 a, the device can be securely held at a second or lowerposition.

Referring now to FIGS. 21-33, the trajectory frame 1100 described above,modified to not require (but can include) the use of MRI and/or CTvisible fiducials 117 and a targeting cannula 200 and to now includeother cooperating components, are shown which can be used for non-MRIimage guided systems such as camera-guided systems C, FIG. 33. Thetrajectory frame 1100 and components may be configured for use with“asleep” or “awake” neurological (e.g., brain) surgical systems. Theframe 1100 and cooperating components can be sterile so as to complywith medical use requirements (and are typically held in a clean orsterile state in packaging prior to surgical use).

FIG. 21 illustrates the trajectory frame 1100 (e.g., also known as atrajectory guide) with the guide 1102 (e.g., also known as a supportcolumn) holding an optical tracking probe 1162 according to embodimentsof the present invention. This tracking probe 1162 includes a pluralityof spaced apart fiducials 1164, typically reflective elements that maycomprise spherical shaped reflective members. The reflective members1164 can be arranged as an array of fiducials 1164 a in a fixedgeometric pattern relative to one another that may be positionallyadjusted as a group. The array can include four (or more) reflectivemembers that can be of any shape, e.g., reflective spheres, dots ortape. The array can be configured to allow the navigation/trackingsystem to generate AC-PC image views. The reflective elements can have areflective coating and may be passive spheres such as those availablefrom Northern Digital Inc. (ndigital.com) as NDI passive spheres thatattach via snap-on posts.

The tracking probe 1162 is held in an elongate tracking probe mount 1160that can include lugs 1168 that releasably attach to the guide 1102 thatis attached to the X-Y support table 132. The tracking probe mount 1160includes upper and lower ends, 1160 a, 1160 b, respectively. The lowerend 1160 b is typically held in the guide 1102 so that it is positionedto extend below the bottom or distal end of the guide 1102 b to be ableto bottom out or contact the skull or scalp of the patient to define adesired trajectory. The optical tracking probe 1162 can be held abovethe top end 1160 a of the mount 1160.

FIG. 23A shows the optical array 1162 with an exemplary mount 1160.FIGS. 23B and 23C illustrate two alternate configurations of the mount1160, each having laterally extending lugs 1168 and a collar 1163 thatsurrounds an upwardly extending stem 1161 that slidably extends into abore in a downwardly extending support member 1162 s of the opticalarray 1162. FIG. 23B illustrates a flat closed upper surface 1163 f ofthe collar 1163 that can abut a flat lower surface of the optical arraysupport member 1162 s. FIG. 23C illustrates that the collar 1163 canhave an open annular channel that receives a lower end of the opticalarray support member 1162 s. The lower portion of the collar 1163 canengage the top of the guide 1102 a.

FIGS. 23A-23C illustrate that the collar 1163 can include at least oneaperture 1165 that allows for a fixation member 1166 to extendtherethrough to lockingly engage the lower end portion of the opticalarray support member 1162 s. Although shown as one fixation member andaperture, a plurality of circumferentially spaced apartmembers/apertures may be used. Also, other fixation configurations maybe used including, for example, clamps, frictional engagement grips,bayonet fittings or other configurations that lock the device 1162 inposition on or in the mount 1160 so that the optical array 1162 does notflex or move other than with the mount 1160 in the guide 1102.

FIGS. 23D-23G illustrate another embodiment of the tracking probe 1162and tracking probe mount 1160. In this embodiment, the tracking probemount 1160 can optionally include a through channel 1169 c and thetracking probe 1162 can include an aligned port 1169 p. One or moredifferent devices can optionally be guided down through the channel 1169c for a desired trajectory provided by the tracking probe mount 1160.The tracking probe mount 1160 can include image fiducials 50F (FIG. 9A)that may include MRI and/or CT visible segments, such as fluid-filledsegments, which may optionally comprise a wall with an enclosed spacecomprising fluid 1169 f surrounding all or part of the open channel 1169c. The MRI/CT visible segments (image fiducials) can comprise afluid-filled spherical member 1169 s at a distal end portion of thetracking probe mount 1160. The trajectory frame 100 may includefluid-filled fiducials 50F about a perimeter of an aperture formed bythe base 110 (FIG. 22B).

FIGS. 22A and 22B illustrate that the trajectory frame 1100 can alsooptionally be configured to hold both the optical tracking probe 1162and an optical reference frame 1200. The optical reference frame 1200,where used, can include an array of reflective members 1204 a, typicallyfour spherical reflective members but other shapes can be used such asthose discussed above with respect to the tracking probe 1162.

In some embodiments, a first planned trajectory can be generated using acamera-based or EM based navigation/tracking system with a correspondingtracking probe 1162 or 1500 (FIG. 34A), for example. A confirmation orconcordance trajectory can be calculated (or fine adjustments made)using the CT and/or MRI image fiducials 50F which can be on the opticaltracking probe mount 1160 or the EM tracking probe mount 1510 (FIG. 34B)and/or trajectory frame 1100. In other embodiments, a targeting cannula200 (FIG. 8B) can be interchangeably placed in the bore of the guide1102 after removing the tracking probe 1162, alone, or the trackingprobe 1162 with the tracking probe mount 1160, (or EM probe 1500 or EMprobe mount 1510, FIGS. 34A, 34B) and used for the concordance orconfirmation/adjustment review trajectory evaluation. In any event,using the CT or MRI Scanner to supplement or confirm the trajectory canreduce any required imaging time from an MRI and/or CT Scanner and yetprovide a precise trajectory.

The reference frame 1200 can be held by a bracket 1300 that is attachedto the trajectory frame 1100. The reference frame 1200 can extend adistance beyond an outer surface of the platform 130 with the fiducials1204 in a fixed geometric pattern that may extend along a common planeor at different planes and can allow for AC-PC image views. Thereference frame 1300, when attached to the trajectory frame 1100, may beparticularly suitable for “awake” brain surgical procedures to trackpatient movement. For “asleep” neuro surgeries, the reference frame 1200may be attached to the trajectory frame 1100 and/or a head fixationframe (not shown).

The reference frame 1200 can be configured to extend from a defined oneof a left side or right side or can be configured to be able to extendfrom a selected either side of the trajectory frame 1100, when lookingfrom a front of a patient. The bracket 1300 can have a dedicated leftside attachment configuration, a dedicated right side configuration or aconfiguration that can be used to extend off either side of thetrajectory frame 1100. Two trajectory frames may be used for bilateralprocedures, each with a respective reference frame 1200 (not shown).

The bracket 1300 can include at least one starburst connector 1302. Thestarburst connector 1302 can allow for positional adjustment of thereference frame 1200 relative to the patient and/or base 110 oftrajectory frame 1100. FIGS. 22, 24 and 25A illustrate that the at leastone starburst connector 1302 can include a starburst connector thatresides closer to the reference frame 1200 than the base 110. Therotational or swivel axis A-A (FIG. 24) can extend perpendicular to thelength dimension of the arm or link 1303.

The trajectory frame 1100 can have three concentric ears 1117 ₁, 1117 ₂,1171 ₃ (FIG. 27C), positioned about the base 110 and can have two thatreside closer together than a third, e.g., the ears 1117 can beasymmetrically oriented about a circle drawn through the centers of theears 1117.

As shown in FIG. 22, the trajectory frame 1100 can have one or moreattachment ears 1117 that extend outside the base 110, above the base110 and under the X-Y support table 132 and/or platform 130. The one ormore ears 1117 can be a plurality of ears 1117 that extend outside aperimeter of the base. The ears 1117 can be the surfaces that supportMRI fiducials 117 (FIG. 3A) when used in MRI-image guided systems. Theears 1117 can have upper and lower surfaces, 1117 u, 1117 b (FIG. 25A),respectively, one or both of which can be planar.

As shown in FIGS. 22 and 25A, the bracket 1300 can have at least oneupright segment 1305 that is attached to a respective ear 1117. As shownin FIGS. 22 and 25A, a pin or screw 1307 can be used to attach theupright segment 1305 to the ear 1117 and the pin or screw 1307 canextend down through the ear 1117, typically through a pin or screwaperture 1117 p and connector aperture 1305 p (FIGS. 26A, 27A). However,the upright segment 1305 can also be bonded, glued and/or ultrasonicallyinserted into or moldably attached or otherwise integrated into arespective ear 1117.

The upright segment 1305 can have a top surface that abuts the bottomsurface of a respective ear 1117 b. Although not shown, the uprightsegment 1305 can have prongs or overlying wall segments that resideabove and below the ear 1117 with a channel that receives and holds theear 117 therebetween for attachment or the upright segment 1305 canreside on the upper surface of the ear and be attached to the ear 1117.The upright segment 1305 can support an outwardly extending linkage orarm 1303 that places the reference frame 1200 at a desired closelyspaced apart position from the base 110. The arm or linkage 1303 canhave a length that is typically between about 0.25 inches to about 3inches and can raise up as it extends outward away from the base 110.

FIGS. 25A, 25B, 26A and 26B illustrate one example of a bracket 1300. Inthis embodiment, the bracket 1300 can have two upright segments 1305,e.g., first and second segments 1305 a, 1305 b, each of which can attachto spaced apart ears 1117. Typically, the upright segments 1305 a, 1305b are connected by a laterally extending straight arm 1306 that is at alevel below the upper surface of the first and second segments 1305 andthat can be below that of the outwardly extending arm or linkage 1303.The bridging or connecting arm 1306 can extend proximate to but underthe arcuate arm 116. The dual upright supports may provide a more stableattachment for the arm 1303 and/or cantilevered reference frame 1200.

The bracket 1300 can include a plurality of the starburst connectors1302, including one forming part of the upright segment 1305 proximatethe base 110 and one residing further away from the base 110 andproximate the reference frame 1200. FIG. 25B shows the upper componentof the starburst connector 1302 u attached to the underside of the ear1117 b. Each can have an axis A-A that is perpendicular to the other.The axis A-A of the upright segment 1305 can allow for front to back orright to left positional adjustment. The axis A-A of the connector 1302proximate the reference frame 1200 can allow up and down adjustment ofthe arm 1303 and thus, the reference frame 1200.

FIGS. 26A and 26B illustrate that the upright segments 1305 are notrequired to have starburst connectors 1302. However, where used,typically only the upright segment closest to the arm or linkage 1303will have the starburst connector 1302 for rotational adjustability ofthe arm or linkage 1303. In any event, the bracket segments 1305 a, 1305b can be reversed to attach to the other ears 1117 so that the link 1303extend from a desired side of the trajectory frame.

FIGS. 27A-27C illustrate another exemplary bracket 1300′. In thisembodiment, a single upright segment 1305 is used to attach to a singleear 1117. FIG. 27A illustrates the bracket 1300′ with the lowercomponent of the starburst connector 1302 b while FIG. 27B illustratesthe upper component 1302 u attached to an underside 1117 b of the ear1117 of the trajectory frame 1100. Again the two axis of rotations A-Acan be orthogonal to each other. The upright segment 1305 can beattached to the first, second or third ear 1117 ₁-1117 ₃.

FIGS. 28, 29A and 29B show the trajectory frame 1100 with theguide/support column 1102 releasably holding a microelectric (MER) probedriver adapter 1170, typically used for “awake” brain surgeries,according to embodiments of the present invention. The probe driveradapter 1170 can hold the MER probe driver adapter body 1171 withmicroelectrode (entry) ports 1172 at a location that positions themicroelectrode ports 1172 exposed above the adapter body 1170 b. Theadapter body 1170 b can have outwardly extending lugs 1178 that engagethe slots in the guide 1102. The MER probe drive adapter body 1171 canhave radially extending tabs 1173 that define a stop for the upperportion of the adapter body 1171 so that it extends a desired distanceabove the lugs 1178 and/or so that the driver engages the probe driveadapter at a desired position. The MER probe drive adapter body 1171 canmatably engage a drive system 1180 (FIG. 30) such as the NEXDRIVE® drivesystem with upwardly/outwardly extending rails 1180 r (FIG. 30) fromMedtronics, Inc. As shown in FIG. 30, the probe drive adapter 1170resides between the rails 1180 r attached to a support frame of theprobe driver system 1180.

FIGS. 31A and 31B illustrate the trajectory frame 1100 holding auniversal tracker 1190 according to embodiments of the presentinvention. The universal tracker 1190 typically includes an array 1194 aof two, three, four or more (typically between about 2-10) (shown asthree) reflective members. The reflective members 1194 are shown by wayof example as spherical reflective members. As discussed with the othertracking probe 1162 above, the reflective members 1194 can have areflective coating, tape and/or other reflective feature detectable by acamera or other tracking system and may be passive spheres such as thoseavailable from Northern Digital Inc. (ndigital.com) as NDI passivespheres that attach via snap-on posts.

The universal tracker 1190 can be held in an elongate tracking probemount 1190 m that can include lugs 1198 that releasably attach to theguide 1102 that is attached to the platform 130. The tracking probemount 1190 m includes upper and lower ends, 1190 a, 1190 b,respectively. The lower end 1190 b is typically held in the guide 1102so that it is positioned to extend below the bottom or distal end of theguide 1102 b to be able to bottom out or contact the skull or scalp ofthe patient to define a desired trajectory. The optical universaltracker reflective members 1190 can be held external of the mount 1190m.

FIG. 31C shows the universal tracker 1190 with the optical (reflectivemember) array 1194 a for releasable attachment to a support column ofthe trajectory frame 1100. The lowest of the reflective members (e.g.,shown as spheres) 1194 a can be held at between about 5-6 mm above thelugs 1198, in some embodiments.

FIG. 31D is a front view of the universal tracker 1190 without theoptical (reflective members) array 1194 a. The tracker mount 1190 mincludes an upwardly extending stem 1191 s that holds the optical arraybracket 1196 and a collar 1192 that can engage the top of the guide1102.

FIG. 32 is a side view of a trajectory frame 1100 illustrating theuniversal tracker 1190 shown in FIGS. 31A-D, replaced by a device (DBSlead) guide 1400 with lugs 1408 that engage guide (e.g., support column)1102 according to embodiments of the present invention.

FIG. 33 is a schematic illustration of a camera-based image guidedsystem S with a software imaging/tracking module and camera trackingsystem C that can be used with the trajectory frame 1100 and variouscomponents discussed herein according to embodiments of the presentinvention.

FIG. 34A illustrates a trajectory frame 100 cooperating with a EMtracking probe 1500 for EM-based tracking systems 10EM. The trackingprobe 1500 can releasably attach to the guide 1102 (e.g., supportcolumn) of the trajectory frame 100. As shown in FIGS. 34A and 34B, theEM tracking probe 1500 can comprise a mount 1510 with outwardlyextending lugs 1508 that engage the slots 1103 of the guide 1102. TheEM-based tracking system 10EM can be any suitable system, such as, butnot limited to, the StealthStation® AxiEM™ surgical navigation systemwith electromagnetic (EM) tracking technology by Medtronic, Inc. The EMtracking can use a single-coil or multiple coil design. The at least onecoil 1505 can include a coil 1505 that resides at a distal end portionor tip of the probe 1500 or at a location above the distal end. Themount 1510 can include a closed channel or an open channel 1510 c thatis sized to slidably snugly hold a (typically rigid or semi-rigid) stemof the tracking probe 1500.

Generally stated, the EM tracking system 10EM can generate anelectromagnetic field around the patient's target anatomy and/or thetrajectory frame 100 using a tracking probe 1500 with the at least oneEM coil 1505 that can be used to triangulate the position ofinstruments, e.g., the guide 1102 of the trajectory frame 100 and/orpatient-tracking devices during surgical navigation procedures. See,e.g., U.S. Pat. No. 8,543,189, the content of which is herebyincorporated by reference as if recited in full herein. EM tracking canbe configured so that it does not rely on line-of-sight between theemitter E (FIG. 35) and the surgical instruments, such as the trackingprobe 1500. The emitter E can be draped and kept outside of the sterilefield and the staff can move in and out of the EM field with minimal orno disruption to the surgical navigation information. Algorithms of theEM system 10EM can monitor the electromagnetic field, including metaldisturbance, to ensure surgical navigation precision. FIG. 35 alsoillustrates that the EM surgical navigation system 10EM can employexternal EM markers 90 on patient anatomy.

The guide 1102 of the trajectory frame 100 can be configured toserially, interchangeably receive the optical and EM tracking/navigationprobes 1162, 1190, 1500 to allow for use in different navigationsystems.

It is contemplated that a pre-op image of a patient's brain can beimported into the EM or camera based system “S” and displayed on thedisplay with tracking information from the tracking probe 1162, theuniversal tracker 1190 and/or the reference frame 1200 or the EM system10EM. Patient images can be obtained the day of surgery with thetrajectory frame 100 mounted to facilitate registration (aligning orbsor anatomical features between the image sets). The trajectory frame 100can be tracked using the EM and/or camera navigation system.

In some embodiments, for “asleep” procedures, the reference frame 1200can be attached to a head fixation frame (not shown). For “awake”procedures, the reference frame 1200 can be attached to the trajectoryframe as discussed above. CT images can be obtained at various pointsduring the procedure, such as at final lead implantation, for example,without requiring constant imaging during a procedure.

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

That which is claimed is:
 1. A trajectory frame for use with a surgicalsystem, comprising: a base having a patient access aperture formedtherein, wherein the base is configured to be secured to the body of apatient; a yoke movably mounted to the base and rotatable about a rollaxis; a platform movably mounted to the yoke and rotatable about a pitchaxis; and an elongated guide secured to the platform, wherein the guidecomprises opposite proximal and distal end portions, wherein the guidecomprises a bore therethrough that extends from the proximal end portionto the distal end portion, wherein the guide is configured to receive atleast one device within the bore, wherein the at least one device isremovably secured to the guide proximal end portion, and wherein the atleast one device that is received within the bore is or comprises anelongate tracking probe mount holding a tracking probe with reflectivemembers arranged in a fixed geometric relationship relative to eachother.
 2. The trajectory frame of claim 1, wherein the proximal endportion is configured with a quick release shape and/or component toremovably, interchangeably and serially secure a plurality of differentdevices.
 3. The trajectory frame of claim 1, wherein the tracking probehas three or four spherical reflective members in the fixed geometricrelationship, which are detectable by a camera-based tracking system. 4.The trajectory frame of claim 1, wherein the at least one device furthercomprises a microelectrode probe adapter.
 5. The trajectory frame ofclaim 1, wherein the tracking probe has a port and the tracking probemount has a longitudinally extending through-channel aligned with theport for slidably receiving at least one surgical device.
 6. Thetrajectory frame of claim 1, wherein the guide proximal end portioncomprises threads formed therein, and wherein the at least one devicecomprises a portion configured to threadingly engage the guide proximalend portion.
 7. The trajectory frame of claim 1, wherein the guideproximal end portion comprises at least one longitudinally extendingslot that merges into transversely extending spaced-apart slots, andwherein the at least one device is removably secured within the guidebore via at least one member extending outwardly from a respectivedevice that cooperates with the longitudinally and transverselyextending slots.
 8. The trajectory frame of claim 1, further comprisinga plurality of user-activatable actuators operably connected to theframe that are configured to translate and rotate the frame relative tothe body of the patient wherein the yoke comprises a first pair ofspaced apart arcuate arms, wherein the platform engages and moves alongthe first pair of arcuate arms when rotated about the pitch axis,wherein the base comprises a second pair of spaced apart arcuate arms,and wherein the yoke engages and moves along the second pair of arcuatearms when rotated about the roll axis.
 9. The trajectory frame of claim1, wherein the base is configured to be secured to the scalp and/orskull of a patient about a burr hole formed therein, wherein the guidebore is configured to guide intra-brain placement of at least one devicein vivo, and wherein the trajectory frame comprises a bracket attachedthereto that has an arm that extends therefrom and holds a referenceframe with a plurality of spaced apart reflective members held in afixed geometry relative to each other.
 10. The trajectory frame of claim1, wherein the platform comprises an X-Y support table movably mountedto the platform that is configured to move in an X-direction andY-direction relative to the platform, and wherein the guide is securedto the X-Y support table.
 11. The trajectory frame of claim 1, furthercomprising: a plurality of spaced apart ears laterally extending outwardaway from the base, the ears having upper and lower surfaces; and abracket with a first upright segment residing under and attached to oneear supporting an arm that extends outwardly therefrom with a starburstconnector on an end portion of the arm configured to engage a referenceframe with an array of reflective members thereon for tracking by acamera based tracking system.
 12. The trajectory frame of claim 11,wherein the bracket includes a second upright segment residing under andattached to a different ear and a bridging arm extending between thefirst and second upright brackets.
 13. The trajectory frame of claim 11,wherein the bracket starburst connector has a first swivel axis thatallows positional adjustment of an end portion of the arm, and whereinthe first upright segment has a starburst connector that has a secondswivel axis that is orthogonal to the first swivel axis.
 14. Thetrajectory frame of claim 1, wherein the at least one device comprisesthe tracking probe mount holding the tracking probe and a microelectrodeprobe driver adapter, and wherein the tracking probe mount and themicroelectrode probe driver each have outwardly extending diametricallyopposed lugs that slidably engage slots in the guide to be releasably,serially secured thereto.
 15. The trajectory frame of claim 1, whereinthe tracking probe mount comprises a collar and a stem extending abovethe collar, the stem having a smaller diameter than the collar and aprimary body of the tracking probe mount extending below the collar, andwherein the collar includes an outer wall with at least one apertureextending therethrough or an upwardly extending protrusion with at leastone aperture extending therethough, the at least one aperture configuredto receive a cooperating fixation member that extends through the atleast one aperture to lock a lower end portion of the tracking probewith the array of reflective members to the tracking probe mount.
 16. Asurgical assembly, comprising: a trajectory frame, comprising: a basehaving a patient access aperture formed therein, wherein the base isconfigured to be secured to the body of a patient; a yoke movablymounted to the base and rotatable about a roll axis; and a platformmovably mounted to the yoke and rotatable about a pitch axis; and anelongated guide secured to the platform, wherein the guide comprisesopposite proximal and distal end portions, wherein the guide distal endportion is positioned above the patient access aperture, wherein theguide comprises a bore therethrough that extends from the proximal endportion to the distal end portion; and a plurality of devices releasablyand serially insertable within the bore of the elongated guide, thedevices comprising a tracking probe mount holding a tracking probe withan array of reflective members and at least one of the followingadditional devices: a microelectrode probe driver adapter, a drill guideand drill bit, a skull fixation device and driver, a deep brainstimulation lead guide and a catheter guide; wherein each devicecomprises opposite proximal and distal end portions, wherein each devicedistal end portion is positioned proximate or inside the patient accessaperture, and wherein each device proximal end portion is removablysecured to the guide proximal end portion.
 17. The assembly of claim 16,wherein the guide proximal end portion comprises at least onelongitudinally extending slot that merges into at least one transverselyextending slot, and wherein the devices are removably secured within theguide bore via at least one lug extending outwardly from a respectivedevice that cooperates with the slots.
 18. The assembly of claim 16,wherein the base is configured to be secured to the scalp and/or skullof a patient about a burr hole formed therein, wherein the guide bore isconfigured to guide intra-brain placement of at least one device invivo, and wherein the trajectory frame comprises a bracket attachedthereto that has an arm that extends therefrom and holds a referenceframe with a plurality of spaced apart reflective members.
 19. Theassembly of claim 16, wherein the platform comprises an X-Y supporttable movably mounted to the platform that is configured to move in anX-direction and Y-direction relative to the platform, and wherein theguide is secured to the X-Y support table.
 20. The assembly of claim 19,wherein the trajectory frame further comprises: a plurality of spacedapart ears laterally extending outward away from the base, the earshaving upper and lower surfaces; and a bracket with a first uprightsegment residing under and attached to one ear supporting an arm thatextends outwardly therefrom with a starburst connector on an end portionof the arm configured to engage a reference frame with an array ofreflective members thereon for tracking by a camera based trackingsystem.
 21. The assembly of claim 20, wherein the bracket includes asecond upright segment residing under and attached to a different earand a bridging arm extending between the first and second uprightbrackets.
 22. The assembly of claim 21, wherein the bracket starburstconnector has a first swivel axis that allows positional adjustment ofan end portion of the arm, and wherein the first upright segment has astarburst connector that has a second swivel axis that is orthogonal tothe first swivel axis.
 23. The assembly of claim 16, wherein the atleast one additional device comprises the microelectrode probe driveradapter, and wherein each device has outwardly extending diametricallyopposed lugs that releasably engage the proximal end portion of theguide.
 24. The assembly of claim 16, wherein the tracking probe mountcomprises a collar and a stem extending above the collar, the stemhaving a smaller diameter the tracking probe collar and a primary bodyof the tracking probe mount that extends below the collar, and whereinthe collar includes an outer wall with at least one aperture extendingtherethrough or an upwardly extending protrusion with a wall having atleast one aperture extending therethough for cooperating with a fixationmember that extends through the at least one aperture to lock a lowerend portion of the tracking probe to the tracking probe mount.
 25. Amethod, comprising: affixing a trajectory frame with a cooperating guideto the skull of a patient, wherein the frame is configured to translateand rotate such that a device held by the guide can be positioned to adesired intrabody access path trajectory; removably securing a trackingprobe with an array of reflective members to the guide, wherein theguide comprises a longitudinally extending bore; identifying atrajectory using a camera and the geometric positions of the array ofreflective members; removing the tracking probe from the guide of thetrajectory frame; then inserting a microelectrode probe driver adapterinto the guide of the trajectory frame; then driving microelectrodesinto the patient's brain using a probe driver attached to the probedriver adapter held by the guide; and then identifying a target implantlocation while a patient is awake.
 26. The method of claim 25, furthercomprising attaching a reference frame to the trajectory frame, thereference frame comprising a second array of reflective members, andtracking movement of a patient's head using the camera and the secondarray of reflective members.
 27. The method of claim 25, furthercomprising removing the microelectrode probe driver adapter; thenremovably securing a catheter guide to the guide; and advancing acatheter through the catheter guide.
 28. A trajectory frame for use witha surgical system, comprising: a base having a patient access apertureformed therein, wherein the base is configured to be secured to a bodyof a patient; a yoke movably mounted to the base and rotatable about aroll axis; a platform movably mounted to the yoke and rotatable about apitch axis; and an elongated guide secured to the platform, wherein theguide comprises opposite proximal and distal end portions, wherein theguide distal end portion is positioned proximate the patient accessaperture, wherein the guide comprises a bore therethrough that extendsfrom the proximal end portion to the distal end portion, wherein theguide is configured to serially receive and removably secure differentdevices within the bore, wherein one of the device is an elongatetracking probe mount holding a tracking probe with at least oneelectromagnetic tracking coil for an electromagnetic surgical navigationsystem.
 29. The trajectory frame of claim 28, wherein the elongatetracking probe mount comprises outwardly extending lugs that engageslots of the guide to removably secure the tracking probe mount to theguide, and wherein the tracking probe mount comprises a longitudinallyextending channel that snugly receives at least a portion of thetracking probe therein.
 30. The trajectory frame of claim 28, whereinthe tracking probe mount comprises a longitudinally extendingthrough-channel for slidably receiving at least one surgical device. 31.The trajectory frame of claim 28, wherein the tracking probe mountcomprises image fiducials electronically detectable as regions withincreased signal to noise ratios in MRI and/or CT images thereof.